secwatch.observer — SEC 8-K summary
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Issuer:     Phathom Pharmaceuticals, Inc. (PHAT)
CIK:        0001783183
Form:       8-K
Filed at:   2023-04-04T23:59:59+00:00
Accession:  0001193125-23-090354
Event type: regulatory
Sentiment:  neutral
Materiality: 0.60
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Phathom provides regulatory update on path to resubmit EE NDA in Q2 2023; launch expected Q4 2023
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- Met with FDA; CRLs solely related to nitrosamine impurity NVP; mitigation includes minor tablet reformulation.
- Stability data shared with FDA; anticipates resubmitting EE NDA in Q2 2023, with combined EE/H. pylori launch in Q4 2023.
- Also plans to submit PAS for H. pylori; FDA action expected in Q4 2023.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1783183/000119312523090354/0001193125-23-090354-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1783183/000119312523090354/d495312d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-23-090354

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer